Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2026-03-31

Brief Summary

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The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook.

Participants can expect to be in the study for 13 weeks.

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Detailed Description

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The Specific Aims of the proposed study correspond directly to the three-step process.

1. In Step 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input.
2. In Step 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook.
3. In Step 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. Primary clinical outcome measure will be depression, secondary clinical outcome measure will be anxiety.

For each participant assigned to a condition, a study team member will meet with them individually to provide them with a copy of the workbook. During this meeting, the study team member will inform the participant that they should complete one chapter per week.

Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook; a Mid-Treatment Assessment four weeks after the distribution of the workbook; a Post-Treatment Assessment #1 eight weeks after distribution of the workbook (when the workbook should be completed); Focus group (after completion of workbook) and, a Post-Treatment Assessment #2 twelve weeks after distribution of the workbook.

Conditions

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Anxiety Depression Depression, Anxiety Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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ACT workbook

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Delivered over 8 weeks of self-guided study and homework assignments.

Control workbook

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

As control condition, reflective journaling will be used.

Interventions

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Acceptance and Commitment Therapy (ACT)

ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Delivered over 8 weeks of self-guided study and homework assignments.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

As control condition, reflective journaling will be used.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Reading level of 6th grade or higher determined by the Wide Range Achievement Test
* Moderate or severe anxiety and/or depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI)
* No active self-harm or active suicidal intent
* No scheduled transfer or release for at least three months
* Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil